Overview
In this role you will shape and drive the Clinical Development strategy for assigned molecules/indications, partnering with cross-functional teams to execute plans that advance patients’ outcomes. You will represent Clinical Development to internal groups and liaise with investigators, KOLs, and regulators to ensure alignment and progress. You will lead health authority interactions and contribute to regulatory filings, briefing packages, and labeling discussions. You will also mentor new CST members and promote a collaborative, fast-paced team culture across locations.
Verantwortungsbereiche
- Develop and implement the CD strategy/plan for assigned molecules/indications
- Represent CD to internal Roche groups and ensure cross-functional alignment
- Collaborate with investigators, clinicians, scientists, and KOLs as well as internal groups (PD, research, BD, commercial, legal)
- Provide clinical science input for early development and Phase I protocols, and late-stage input for Phase I/II
- Lead health authority interactions and drive regulatory submissions and documentation (briefing packages, label/packaging language)
- Train and mentor new CST members
- Ensure progress monitoring and issue resolution against study objectives and plans
Zentrale Anforderungen
- Board Certified/Board Eligible MD/MBBS with Neurology specialization
- 6+ years pharma/biotech R&D experience and recognized expert
- Late-stage experience in Neurology and interaction with health authorities
- Experience with pharma partnerships (acquisitions, JVs, strategic alliances)
- Significant experience designing and conducting clinical trials
- Proven ability in late-stage development and mentoring
- Ability to foster an inclusive, productive team-based culture in fast-paced settings
- Experience data analysis, interpretation, and scientific writing (manuscripts, protocols, regulatory docs)
- Outstanding communication skills (long-form and concise) and ability to influence cross-functional partners
- Experience with diverse clinical trial designs
- Preferred: clinical experience in multiple sclerosis
- Leadership experience
- strong interpersonal skills
- excellent written and verbal communication
- influencing and relationship-building
- clinical trial design and execution
- regulatory submissions and HA interactions
- data analysis and interpretation
Senior Medical Director, Product Development, Neurology in Basel Arbeitgeber: Genentech
Als Arbeitgeber im Bereich Biometrie bietet Roche eine inspirierende Arbeitsumgebung, in der Innovation und Teamarbeit im Mittelpunkt stehen. Unsere Mitarbeiter profitieren von umfangreichen Entwicklungsmöglichkeiten, einem flexiblen Arbeitsmodell und einem attraktiven jährlichen Bonus, während sie an der Schnittstelle von Technologie und Gesundheitswesen arbeiten, um die Patientenversorgung zu verbessern. In unserem dynamischen Team fördern wir eine Kultur des Wissensaustauschs und der Zusammenarbeit, die es jedem ermöglicht, einen bedeutenden Beitrag zu leisten.
